Skip to main content
OpenTrials
Completed

NCT Number: NCT02681640

uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-verified breast cancer
  • Primary tumor more than 2 cm (ultrasound or clinically)
  • The participants must be capable of understanding and giving full informed written consent

Exclusion criteria

  • Pregnancy
  • Lactation/breast feeding
  • Weight above 140 kg
  • Treatment with neoadjuvant chemotherapy
  • Known allergy towards the IMP

Treatment and study plan

68Ga-NOTA-AE105

Other

One injection of 68Ga-NOTA-AE105

Positron Emission Tomography PET/CT

Device

Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT

Primary outcomes

  1. Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer

    Time frame: 1 hour

    Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the presence of metastases in axillary lymph nodes ("spread"/"no spread"). Lymph Node sampling and histopathology determine true positives and true negatives.

Secondary outcomes

  1. Number of axillary lymph node metastasis

    Time frame: 1 hour

    Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of metastases in axillary lymph nodes. Lymph node sampling and histopathology determine true positives and true negatives.

  2. Number of distant metastases

    Time frame: 1 hour

    Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of distant metastases. Biopsy/follow up imaging will be used as reference.

Other outcomes

  1. Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105

    Time frame: 0-60 minutes

    The first 5 patients will be subjected to 60 minutes of dynamic PET imaging covering the breast tumor area, starting at the time of injection. The PET scan will be divided into 12 time frames of each 5 minutes. The time frame with the best visual tumor to background contrast, will be designated as the optimal time point p.i. for uPAR-PET/CT

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Curasight ApS

Registry information

Official study title

Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2016
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.